Current API product portfolio
Alendronate sodiumSpecification:
|
|
| chemical name: | (4-amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt |
| molecular formula: | C4H12NNaO7P2, 3H2O |
| structural formula: |  |
| molecular weight: | 325.1 |
| CAS Registery number: | 121268-17-5 |
General information: Sodium alendronate is white or almost white crystalline powder, soluble in water, practically insoluble in methanol and methylene chloride. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR spectrum B. chemical reaction |
corresponds to sodium alendronate CRS gives reaction of sodium |
Ph. Eur. |
| Appearance of solution | clear and not more intensely coloured than reference solution B7 or BY7 | Ph. Eur. |
| pH | 4.0 to 5.0 | Ph. Eur. |
| Related substances (HPLC): - impurity A - other single impurity - total impurities |
not more than 0.1% not more than 0.10% not more than 0.5% |
Ph. Eur. |
| Phosphate and Phosphite (HPLC): - phosphate - phosphitenot more than 0.5% |
not more than 0.5% not more than 0.5% |
Ph. Eur. |
| Heavy me |
not more than 20 ppm | Ph. Eur. |
| Loss on drying | 16.1% to 17.1% | Ph. Eur. |
| Content of alendronate sodium calculated on the dried substance (HPLC) | 98.0% - 102.0% | Ph. Eur. |
| Residual solvents: - methanol |
not more than 500 ppm |
POLPHARMA |
Latest news
CEP for Baclofen available
Monday, 02-01-2012
Polpharma has been granted Certificate of Suitability (CEP) by the European Directorate for the Quality of...
Polpharma – the most innovative company in Poland
Friday, 20-05-2011
Polpharma ranked first as the most innovative company in Poland, in a research study run by the Institute...
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex
Friday, 08-10-2010
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex for the...
Co-operation between Polpharma and RPG Life Sciences
Tuesday, 05-10-2010
RPGLS and Polpharma announced their co-operation in the development and manufacture of Active...